肤康涂膜剂的制备与质控研究

目的研制肤康涂膜剂。方法用卡波姆-940作涂膜剂基质，制备了肤康涂膜剂，建立了酸碱度、卫生学、含量测定等质控方法，进行了加速试验和室温留样考察。结果pH值4．5-5．0，卫生学检查符合规定，含量测定水杨酸平均回收率99．68％，RSD=0．79％(n=6)。酮康唑平均回收率100．81％，RSD=0．95％(n=6)，并且涂膜剂稳定无变化。结论制备该涂膜剂工艺简单，所得制剂质量可控，性质稳定，可满足临床用药需求。

Preparation and study on the quailty control of Fukang balm

OBJECTIVE To develop and study the quality control of Fukang balm.METHOD Using carbopol-940 as balm stroma, the Fukang balm was prepared satisfactorily. The quality studies, including acidic degree detection, hygienical test and quantitative analysis of main components were performed. The stability of balm was also observed.RESULTS The average recoveries for salicylic acid and keloconazole were 99.68% and 100.81 with the RSD 0.79%(n=6) and 0.95%(n=6), respectively. The pH of balm was 4.5~5.0, and the result of hygienical test accorded with the standard. No obviously change of the balm was found in centrifugation test, thermostability test, cold test and normal temperature keeping test.CONCLUSION The balm is useful drug with preparation simple, quality control easy and stability.